There are two reasons the FDA and the industry have been under pressure to strike a deal: (lack of) resources and criticism. According to Medical Marketing and Media the agency reviewed 9,285 consumer promotions in 2005 – up from 8,417 in 2004 – and the number of consumer promotions is thought to have skyrocketed since the implementation of PhRMA’s DTC guidelines late last year.”
In addition, as criticism of DTC advertising has increased, so have the calls for the FDA to increase its oversight of ad campaigns. The industry is seeking to cover its bases by having the agency review more of its commercials, but the FDA is falling behind.
While the PDUFA has injected much-needed funds into the FDA, it too has come under criticism. Industry opponents say that the PDUFA makes the FDA beholden to the very agency it is trying to regulate. If the FDA is taking money from drug firms, they argue, it can’t be objective.
However, unless Congress is going to increase the agency’s budget by at least $300 million to cover the shortfall if the PDUFA was repealed, critics will have to accept the current system.
For more on this issue, please see these articles from other blogs:
- The Pharma Marketing Blog: Pay Per DTC Ad View Update
- Eye On FDA: What Will the Next PDUFA Look Like?
- PharmaGossip: FDA pitches for post marketing personnel
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